Systems and methods for tissue treatment

ABSTRACT

A method for aesthetic soft tissue treatment includes placing at least one applicator in contact with the patient&#39;s body. The applicator has at least one electrode. Electrotherapy and radio frequency therapy are provided to the soft tissue, optionally with overlay or sequentially. A handheld applicator may be used, with the applicator moving during the therapy, which may provide muscle stimulation in the patient, or provide an analgesic effect during the treatment. A spacing object may be positioned between the skin of the patient and the applicator.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/959,092, filed Oct. 3, 2022, which is a continuation of U.S. patentapplication Ser. No. 16/727,458, filed Dec. 26, 2019, now U.S. Pat. No.11,458,307, which is a continuation of U.S. patent application Ser. No.15/603,162, filed May 23, 2017, now U.S. Pat. No. 10,583,287, whichclaims priority to and benefit of U.S. Provisional Application No.62/340,398, filed May 23, 2016, all of which are incorporated herein byreference in their entireties.

TECHNICAL FIELD

The field of the invention is devices and methods for providingaesthetic and therapeutic soft tissue treatment via application of aradio frequency field (RF) and electric currents into the human and/oranimal soft tissue.

BACKGROUND

Skin tightening, wrinkle reduction, removal of cellulite, skin lesions,breast and lips enhancement, reduction of fatty tissue, muscle building,strengthening and/or body contouring are aesthetic treatments for whichthere is a growing demand. Aesthetic therapy commonly includes theapplication of different treatment energy sources, such as lightsources, radio frequency energy sources, ultrasound energy, electricenergy or other sources. Every source of energy mentioned above may havesome beneficial effect.

Energy is focused to skin and/or to lower layers of body soft tissue.Human skin is composed of three basic layers: the epidermis, the dermisand the hypodermis. The epidermis is composed of the outermost layers ofcells in the skin. The epidermis is a stratified squamous epithelium,composed of proliferating basal and differentiated suprabasalkeratinocytes which acts as the body's major barrier against aninhospitable environment. The dermis consists of collagen, elastictissue and reticular fibers. The hypodermis is the lowest layer of theskin and contains hair follicle roots, lymphatic vessels, collagentissue, nerves and also fat forming a subcutaneous white adipose tissue(SWAT).

Energy may be delivered to soft tissue in order to stimulate skeletalmuscle contraction, to treat fat, fibrous tissue, blood vessels and/orother supporting matrix that soft tissue include. Fat is composed mostlyof adipocytes. It is possible to distinguish different types of fattissue but in general, for aesthetic treatment, of primary interest isvisceral fat located around internal organs and subcutaneous fat in thehypodermis and/or beneath the skin but above skeletal muscle.

Invasive therapies for body and/or skin enhancement such as skintightening, wrinkle reduction, cellulite reduction, skin lesions, breastand/or lips enhancement, reduction of fatty tissue and others may beassociated with relative long recovery time, discomfort during and/orafter treatment (e.g. accompanying liposuction) and increased healthrisk. Conventional non-invasive treatments for body and/or skinenhancement includes drugs, ointments with active agents, exercise,dieting or combinations of these treatments. These may not be effectiveor even possible under certain circumstances and therefore the resultsmay disappoint.

Application of RF energy to the tissue may have several benefits on thebody and skin function and/or appearance. Nevertheless, methods anddevices used for non- invasive ways for improving skin visual appearanceand/or body shape and contour by delivering RF energy source of energymay result in irritation of the skin and/or other soft tissues, painfulapplication especially for high intensity stimulus, discomfort duringthe treatment, lack of deep tissue stimulation, inappropriatelocalization and/or inhomogeneity of the delivered energy to the treatedtissue. Some existing devices and therapies cannot compensate forunexpected circumstance which may occur during the treatment, resultingin treatment which can be insufficient, non-homogenous or risky.

Another problem is that treated cells are accumulated in the soft tissueduring and/or after treatment. Accumulation of treated cells may slowhealing or cause inflammation and safety concerns.

SUMMARY

It is an object of the present method and/or device to introduce anapparatus and method for improving skin viability, skin and bodyrejuvenation, skin tightening, scar removing, spider veins removing,restoring and restructuring collagen in the soft tissue body shaping(e.g. butt lifting, breast lifting etc.), body contouring,circumferential reduction, cellulite removing, adipose tissue reduction,adipose tissue removing, muscle relaxation, relaxation of muscle tone,muscle building, muscle strengthening, treating and stimulating pelvicfloor tissue and adjacent muscles, remodeling of outer part of genitalstreat sexual dysfunctions, treat or reduce incontinence problems,accelerate neocolagenesis, improving blood flow, lymph flow, stimulationof lymph nodes, movement of the vessels, bruise removing, reduceswelling, enhancing vitamin D metabolism, restoring nerve signaltransfer, accelerate body metabolism, accelerate cell metabolism,pigmentation disorders, tattoos removal, stress relive, micro-dermalabrasion, hair removal, shortening of recovery time after injury and/orother skin and body affliction using application of RF energy andelectrical stimulation to the soft tissue.

Different body parts may be treated, e.g.: saddlebags, abdomen, lovehandles, bra fat, arm, buttocks and/or others. During one session one ormore body parts may be treated.

The device and/or method are based on synergic effect of combinedelectrotherapy and RF therapy provided by one or more applicators.Therapies may be provided simultaneously, consecutively or with partialoverlay.

One or more applicators with a source of energy able to provideelectrotherapy and/or RF therapy may be stationary and/or movable. Thedevice may include one or more applicators designed as handheldapplicator(s) and/or applicators attached to patients body automaticallyoperating.

The device and method is targeted mostly to people with BMI (body massindex) in range from 18 to 40.

Currently no device and/or method is known having movable applicatorswith sequential or simultaneous combination for effectively applyingelectrotherapy (for mainly analgesic effect and/or muscle stimulation)and/or RF therapy for aesthetic treatment.

Combinations of electrotherapy with RF therapy provide a synergic effectas described below. A handheld applicator may be personalized accordingto an individual patient's needs. The applicator may be able to changetargeting and parameters of the treatment during the treatment sessionwithout stopping the treatment. The present device and method mayprovide high treatment effectivity, shortening time of one treatmentsession, decreasing treatment costs and also provide long lastingresults. The device and/or method may have a lower initial cost of thedevice against equipment covering whole body part treatment techniquesthat require more or larger treatment energy sources. More complicatedand more expensive hardware and software components may be avoided whileproviding homogenous effective treatment with minimal health risks.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG.1 is a schematic diagram of a treatment system.

FIG. 2 illustrates example of thermal gradients.

FIG. 3 is a schematic representation of a spacing object.

FIG. 4 is schematic representation of cooperation multiple applicatorsacross the patient body.

FIG. 5 is a partial perspective view of an embodiment of the beltproviding hardware pattern.

FIG. 6 is a schematic diagram of treatment elements in the applicators.

Glossary

Stimulating signal is a signal inducing a physiological effect in thepatient's body e.g. a muscle contraction.

Electrotherapy or electrostimulation or electro-stimulation orelectrical stimulation is the application of electrical energy (current)into the soft tissue for medical and aesthetic treatment with minimaland/or no thermal effect in soft tissue. Electrotherapy may havedifferent targeted soft tissue and/or stimulating effects (e.g.:analgesic, muscle contraction, muscle relaxation and/or other asdescribed below) depends on electrotherapy parameters. One or moreelectrotherapy effects or targeting may be combined during one treatmentsession.

RF therapy provides radio-frequency waves into the soft tissue in orderto provide thermal effects in the patient's soft tissue. RF therapy mayhave different targeted soft tissue and/or stimulating effect (e.g.:skin tightening, cellulite removing, reduction of number and/or volumeof adipose cells, collagen recovery and restructuring and/or othereffects as described below) depending on RF therapy parameters. One ormore RF therapy effects or targeting may be combined during onetreatment session.

A treatment session starts with a first treatment therapy and ends withthe last treatment therapy described below where delay between twoconsecutive therapies is no longer than 100 minutes.

RF therapy is application of electromagnetic waves into the soft tissue,with at least some thermal effect in soft tissue.

Soft tissue includes skin, muscle, fat, fibrous tissue, nervous tissue(e.g. neurons, motor neuron, and neuromuscular junction) and/or othersupporting matrix.

Parameters of the therapy may be any parameter that can influencetreatment therapy (e.g. intensity of the delivered energy, frequency ofdelivered energy, shape of delivered energy and its modulation, phaseshift between several waves, targeting of the energy source, type of theenergy source, time interval between application one/or more, the sameor different types of the energy source, duration of the treatmenttherapy, sequence of the treatment therapy, number of the applicators,position of one or more applicators, geometry of the applicator, coolingand/or heating during the treatment, method of the treatment and otherparameters that could provide changes in the treatment therapy).

A treatment energy is an energy with a treatment effect (e.g. musclecontraction, heating of the soft tissue etc.). Preferred treatmentenergy sources are electrodes providing RF therapy and/orelectrotherapy. Treatment energy is included in RF waves and/or electriccurrent.

Therapy is at least one of electrotherapy and/or RF therapy.

Aesthetic treatment is one or more of: skin tightening, wrinklereduction, removal of cellulite, skin lesions, breast and lipsenhancement, reduction of fatty tissue, muscle building, strengtheningbody shaping, body contouring and/or other skin and body affliction.

Viability is better resistance against external influences and removingof some skin affliction as acne treatment, scar removal.

Rejuvenation is younger appearance, removing symptoms of aging.

Skin tightening is change in the helical structure of collagen andresults in a micro inflammatory stimulation of fibroblasts, whichproduces new collagen (neocollagenesis) and new elastin(neoelastogenesis), as well as other substances to enhance dermalstructure (breast, lips enhancement, wrinkle reduction and others).

Body shaping is loss of fat but also muscle strengthening, increasingmuscle definition and volume of the muscle.

Body contouring is loss of fat (as fat is defined above).

Signal and energy has the same meaning in the manner of delivered energysuch as an electromagnetic field, RF field by electrode into the softtissue and/or electrical energy.

The pelvic floor is formed in a bowl-like structure and contains tissues

DETAILED DESCRIPTION

The device and method may include one or more applicator providing RFtherapy and/or electrotherapy. The device may include heating/coolingmechanism. Patient surface may be cooled or heated for the reason ofminimizing discomfort, influence of RF therapy tissue penetration and/ordecrease health risk.

Cooling/heating may be provided by thermoelectric element withheating/cooling mechanism based on Peltiere's effect and/or heatingcooling may be provided by thermal diffusion provided by heated/cooledliquid, air and/or other material with good thermal conductivity.Heating may be also provided by treatment source of energy e.g.: lightemitting source of energy, RF source of energy, ultrasound, source ofpositive and/or negative pressure applied to the patient's surface etc.

Heated or cooled may be directly patient's body and/or any part of thedevice (e.g. applicators head).

Warming of the tissue is based on dielectric characteristic of thetissue. Heating and/or cooling of the soft tissue may play a significantrole because of the soft tissue dielectric characteristic influenced byblood flow in the tissue. Temperature of the soft tissue also influencedmetabolism of the cells and organism. While the conductivity of softtissue increases with the temperature, cooling of the soft tissue mayresult in less electrical conductivity. These properties may help withtargeting of the delivered energy into the soft tissue. Heating and/orcooling during, before and/or after treatment session may be providedvia delivering of the energy via therapy, by cooling/heating pads,plates based on thermal diffusion principle, spacing object and/or gels.

Some component of the device may be cooled to prevent overheating.

The present devices may have several possible embodiments based oninvasive and/or non-invasive methods. The device sand methods usesynergic effects of combination RF therapy with electrotherapy.

According another embodiment RF therapy and electrotherapy may be alsocombined with any one or more other treatment energy sources: e.g.heating energy source, light energy source, ultrasound energy source,shock wave energy source and/or magnetic field energy source. RF therapyand also RF electrodes may be replaced by any other(s) treatment energysource described above.

RF energy may selectively treat different tissues based on theirdielectric properties and localization. Applied RF field affects treatedsoft tissues mainly by thermal effect. However, RF field may alsoinfluence ions and partially charged molecules in the patient's body.This effect may be beneficial in different types of therapies and mayprovide therapy faster, safer and more effective treatment.

On the other hand the electrotherapy is founded on effects where anelectric current (a) passes through the body, and locally changes tissuepolarization and ion balance that effect electric potentials in the softtissue. The effect of electrotherapy may be muscle contraction, localanalgesia and/or creating local potentials that influenced cellmetabolism, membranes permeability, body metabolism and dielectriccharacteristic of the soft tissue. Electrotherapy may also heat specificsoft tissue structures based on tissue resistivity. According to oneembodiment the RF energy source and electrical stimulation may be usedsimultaneously or in sequence with one or more energy sources.

Electrotherapy maybe used in order to improve: analgesia, tissueregeneration, relaxation, partly tissue ionization, muscle building,muscle strengthening and/or others mentioned in the document.Combinations of above mentioned electrotherapy effects and RF therapyhave desirable synergic impact on the soft tissue treatment.

Synergistic use of electro-stimulation of skeletal muscle fibers and/orother soft tissue by using electrotherapy and application of RF fieldhas several benefits. Repeated contraction of muscle fibers improveseffect to lymphatic and blood circulation in local and peripheraltissue. Increased blood circulation has positive effect to homogeneityand dissipation of delivered energy into the targeted tissue. Combinedtherapy (in simultaneous and/or sequential use) minimizes risk ofcreating of hot spots and consecutive unwanted soft tissue injury duringthe treatment. Without being bound to the theory it is believed that theincreased blood flow in the target soft tissue and/or peripheral softtissue has substantial influence to removal of cellulite and/or fattissue.

Another method to reduce adipose cells is skin massaging by electro-stimulation. This method is based on improving of blood circulation andincreasing fat metabolism. Improved effect of blood, lymphaticcirculation and fat metabolism may be provided by skeletal musclestimulation.

Electrotherapy may be provided simultaneously, with some overlay orsequentially, before and/or after application of RF therapy. Targetingof electrotherapy may be provided to the same and/or to the differenttarget area as RF therapy is targeted. Electrotherapy and/or RF therapymay be provided by different types of pulses and/or by continualstimulation. Energy of RF therapy and/or electrotherapy may be modulatedin different manners (e.g. shape of the signal and his envelop-curveoutlining extremes of the signal, polarization of the signal, intensity,frequency, timer between one or more pulses and/or others modulation ofdelivered energy into the patient soft tissue).

An advantage of electrotherapy is targeting of the energy into concretemuscle fibers or muscle groups. Contracting of muscle fibers may be usedfor internal massage of target and/or adjacent tissue. This massagephenomenon is beneficial to lymphatic and blood circulation that causeacceleration of metabolism. Faster metabolism provide better treatmentresult and more effective treatment which means shorting the therapytime and the effect may be long lasting in comparison with prior artmethods. Increased lymph flow, blood flow and metabolism activity causedby electrostimulation may help to remove necrotic cells damaged duringRF therapy that lower risk of panniculitis.

According to another embodiment a beneficial effect is to treat thecells in order to induce apoptotic death. Due to the combined effect ofthe RF therapy and electrotherapy and increased blood and lymphcirculation, the cells at the targeted area are treated morehomogenously and removing of cells is faster.

To improve the treatment effects, the electrotherapy may be used also inseveral other ways: analgesia, tissue regeneration, relaxation, partlytissue ionization, muscle building, muscle strengthening and/or othersmentioned in the document. Combinations of above mentionedelectrotherapy effects and RF therapy have desirable impact on the softtissue treatment.

Analgesic effects of electrotherapy may be used to minimize discomfortduring the treatment. Some oversensitive individuals frequently haveuncomfortable and/or painful feelings during the treatment if thetreatment therapy is running in the range of safe threshold limits. Ifthe delivered energy would be in comfortable limits for oversensitiveindividuals, treatment therapy would be inefficient, that is the reasonwhy analgesic effect of electrostimulation is desirable during the RFtherapy.

Without being bound to the theory, it is believed that theelectrotherapy may also improve localization of RF therapy, becausethrough electrotherapy it is possible to change impedance in softtissue. Partial ionization of some tissue could also improvelocalization of delivered RF energy and make therapy faster and moreeffective.

It is possible to combine different effect of electrotherapy (e.g.analgesic and/or muscle stimulation) and/or RF therapy at the sameand/or different time and/or at the same or different areas. This may beused to influence treatment results (e.g. tissue repair, improvecutaneous perfusion during and/or after treatment, comfort during thetreatment, effectiveness of the treatment and/or other treatment processparameters and results).

Another synergic use of warming up tissue by an RF field andelectrotherapy is improvement of muscle relaxation after muscle stimulusreverberation. Tissue warm up accelerates tissue regeneration andprevents or minimizes risk of muscle injury.

The applicator may use three types of the electrodes used as a treatmentenergy source. A first type of the electrode may be used as a source ofenergy for electrotherapy and also RF therapy. A second type of theelectrode may provide just electrotherapy and the third type of theelectrode may provide just RF therapy. One applicator may combine eachtype of the electrodes or just some of them.

In one embodiment the applicator may be stationary adjacent to thepatient surface. In another embodiment moving the applicator or multipleapplicators may be advantageous.

The one or more applicators may be placed or moved in a chosen geometrypattern comprising of e.g. linear, wavy circular, elliptical, zigzag,polygonal, oval, irregular, curvilinear or their combination. Thismoving may be replicated by placing one or more stationary applicatorsin position and switching over relevant electrodes, without moving theapplicators.

The same possible movements of one or more applicators may be consideredfor moving the electrodes.

The applicator may have a head with removable extensions. Headextensions may be specialized for different kinds of therapies.Extension heads may have different sizes, shapes, geometry (e.g.different distance between RF electrodes that influenced treatmentdepth), numbers and type of the treatment energy sources (e.g. type ofthe electrodes) and may be made of different materials (e.g. ceramic,silicone, metal and/or polymeric materials). The applicator's extensionheads may be changed during the treatment session based on treated bodypart or individual patient's needs. The type of the extension head maybe recognized automatically by the device and/or the operator maydistinguish type of the extension head in user interface 103 of FIG. 1 .

The applicator may include at least one RF electrode operating inmonopolar, bipolar or multipolar mode and at least one electrodeproviding electrotherapy operating in monopolar or bipolar mode.

A handheld applicator may include one or more RF electrodes and one ormore electrodes providing electrotherapy may be attached to patient bodyseparately from the handheld applicator and/or RF therapy may be locatedin the patient's body (e.g. in the vagina) in order to provide optimaltargeting of treatment energy.

Electrodes as the treatment energy sources may communicate each other nomatter on type of the electrodes and/or between the same type of theelectrodes.

One or more electrodes may be modularly connected to the applicator tovary the treatment surface, distance between electrodes and providetreatment easier, more effective, faster and/or safer. Electrodes may becontrolled individually and/or in group consists of at least twoelectrodes.

Controlling the electrode by control unit 102 (FIG. 1 ) includeschanging parameters of produced energy: intensity, flux density, timebetween pulses, shape of signal, phase of individual pulses, type ofproduced therapy and/or switching on/off individual electrode orelectrodes. Controlling of the electrode may be automatic by the device,according treatment protocol and/or may be changed by the operator.

Control unit 102 may be part of one or more applicators 104, individualelectrodes and/or may be located out of the applicator.

The applicator and/or electrodes may be created from rigid or at leastpartly flexible material adaptable to curved patient's body surface.

Transfer of electrical and/or RF energy into the soft tissue and may bebased on capacitive, inductive and/or resistive energy transfer.

RF therapy provides electromagnetic field which heats soft tissue. Heatis produced as a resistive loses of electromagnetic energy. RF therapymay be also used for the reason of pre-heating of the soft tissue thatmay influence soft tissue dielectric parameters as was mentioned above.Pre-heating before during and/or after electrotherapy or other RFtherapy treatment may be provided by the same applicator's electrode(s)providing other RF therapy treatment (e.g. removing adipose tissue,heating of collagen fibers etc.) and/or by specific RF electrodesdesigned for pre-heating purpose.

RF thermal stimulation results in micro inflammatory stimulation offibroblasts, which produce new collagen (neocollagenesis) and/or newelastin (neoelastogenesis), as well as other cells to enhance dermalstructure.

Treatment by electromagnetic field and a spacing object enables creategradients across the soft tissue of the patient. Targeting of a thermalgradient by applied electromagnetic field and continuous but morepreferably sequential heating and/or cooling of the patient surface bythe spacing object and/or by other above mentioned method may improvethe effect of the treatment and minimize health risk.

RF thermal stimulation of adipose tissue is also believed to result in athermal- mediated stimulation of adipocyte metabolism and augmentedactivity of lipase-mediated enzymatic degradation of triglycerides intofree fatty acids and glycerol. Induction of apoptosis and/or necrosis offat cells are another proposed mechanism for removing of fat.

RF therapy can be applied to the soft tissue in various manners. Thetreatment system may use bipolar electrodes, where electrodes alternatebetween active and return function and where the thermal gradientbeneath electrodes is during treatment almost the same. The system mayalternatively use monopolar electrodes, where the so called returnelectrode has larger area than so called active electrode. The thermalgradient beneath the active electrode is therefore higher than beneaththe return electrode

A unipolar electrode may also optionally be used. During unipolar energydelivery there is one electrode, no grounding pad, and a large field ofRF emitted in an omnidirectional field around a single electrode.

The electromagnetic field used for heating the soft tissue may be aradiofrequency field or microwave field, typically in a range of 0.1 MHzto 25 GHz. Waves of the RF therapy may be delivered preferably in rangefrom 100 kHz to 3 500 kHz or 6 765 to 6 795 kHz or 13 553 to 13 567 kHzor 26 957 kHz to 27 283 kHz or 40.66 to 40.7 MHz or 433.05 to 434.79 MHzor 902 to 928 MHz or 2 400 to 2 500 MHz or 5 725 to 5 875 MHz or 24 to24.25 GHz or 61 to 61.5 GHz or 122 to 123 GHz or 244 GHz to 246 GHz oroptionally at other frequencies as well.

RF electrodes may be in contact with the patient's body and/or may bespaced from the patient's body contact with air gap and/or by spacingobject or other material.

Energy flux density of RF therapy is preferably in the range of 0.01mW·mm⁻² to 10 000 mW·mm⁻², 0.1 mW·mm⁻² to 5 000 mW·mm⁻², or 0.5 mW·mm⁻²to 1 000 mW·mm⁻².

Energy flux density (energy flux density on the electrode surface) ofthe electromagnetic field in noncontact mode, where electrodes providingRF signal are spaced from the patient body by an air gap may bepreferably in range between 0.01 mW·mm−2 and 10 W·mm−2, more preferablyin range between 0.01 mW·mm−2 and 1 W·mm−2, most preferably in rangebetween 0.01 mW·mm−2 and 400 mW·mm−2.

Energy flux density of the electromagnetic field in contact mode(including the direct contact of electrodes coated by thin layer ofinsulator) may be preferably in range between 0.01 mW·mm−2 and 2 000mW·mm−2, more preferably in range between 0.01 mW·mm−2 and 500 mW·mm−2,most preferably in range between 0.05 mW·mm−2 and 280 mW·mm−2.

Energy flux density of the electromagnetic field in noncontact modewhere electrode is spaced from the patient body by spacing object orother material with beneficial dielectric parameters e.g.: bolus filledwith water, silicon and/or other materials) may be preferably in rangebetween 0.01 mW·mm−2 and 500 mW·mm−2, more preferably in range between0.01 mW·mm−2 and 240 mW·mm−2 or even more preferably in the rangebetween 0.01 mW·mm−2 and 60 mW·mm−2 or the most preferably in rangebetween 0.05 mW·mm−2 and 12 mW·mm−2.

The source of RF waves and/or electrotherapy may be at least oneelectrode. When the only one electrode is applied, the electrode mayserve as both the RF and the electrotherapeutic source. The therapiesmay be applied together, successively or in overlap. The electrode mayconsist of electrode itself and coating, wherein the coating may notcover the whole surface of electrode.

The soft tissue is heated to 10-70° C. more preferably to 20-60° C.,most preferably to 30-50° C.

The main effects of electrotherapy are: analgesic, myorelaxation,iontophoresis, and at least partial muscle stimulation causing at leastpartial muscle fiber contraction and anti-edematous effect.

Each of these effects may be achieved by one or more types ofelectrotherapy: galvanic current, pulse direct current and alternatingcurrent.

Galvanic current (or “continuous”) is a current that may have constantelectric current and/or absolute value of the electric current is inevery moment higher than 0. It may be used mostly for iontophoresis, orits trophic stimulation (hyperemic) effect is utilized. At the presentinvention this current may be often substituted by galvanic intermittentcurrent. In some preferred embodiment galvanic component may be about95% but due to interruption of the originally continuous intensity thefrequency may reach 5-12 kHz, in more preferred embodiment 5-9 kHz, inthe most preferred embodiments 5-8 kHz.

The pulse direct current (DC) is of variable intensity but only onepolarity. The basic pulse shape may vary. It includes e.g. diadynamics,rectangular, triangular and exponential pulse of one polarity. Dependingon the used frequency and intensity it may have stimulatory, tropic,analgesic, myorelaxation, iontophoresis, at least partial musclecontraction and anti-edematous effect and/or other.

Alternating Current (AC) where the basic pulse shape mayvary—rectangular, triangular, harmonic sinusoidal, exponential and/orother shapes and/or combination of mentioned above. It can bealternating, symmetric and/or asymmetric. Use of alternating currents incontact electrotherapy implies much lower stress on the tissue under theelectrode. For these types of currents the capacitive component of skinresistance is involved, and due to that these currents are very welltolerated by the patients.

AC therapies may be differentiate to five subtypes: TENS, Classic(four-pole) Interference, Two-pole Interference, Isoplanar Interferenceand Dipole Vector Field. It also exist some specific electrotherapyenergy variants and modularity of period, shape of the energy etc.

Due to interferential electrotherapy, different nerves and soft tissuestructures by medium frequency may be stimulated preferably in a rangeof 500 Hz to 12 kHz or in amore preferred embodiment in a range of 500to 8 kHz, or 500 to 6 kHz, creating pulse envelopes with frequencies forstimulation of the nerves and tissues e.g. sympathetic nerves (0.1-5Hz), parasympathetic nerves (10-150 Hz), motor nerves (10-50 Hz), smoothmuscle (0-10 Hz), sensor nerves (90-100 Hz) nociceptive fibres (90-150Hz).

Electrotherapy may provide stimulus with currents of frequency inpreferred embodiment in the range from 0 Hz to 12 kHz or in morepreferred embodiment from 0 Hz to 8 kHz or in the most preferredembodiment in range from 0 Hz to 6 kHz.

Time between two pulses and/or time between two band of pulses (burst)may be variable depend on some function and adjustable to type oftherapy and type of the patient.

According to one embodiment an analgesic effects may be achieved. Theanalgesia is beneficial during the treatment of high dose RF therapy andin order to make therapy more comfortable. Some oversensitiveindividuals may have uncomfortable and/or painful feelings during thetreatment therapy event if the treatment runs within the range of safethreshold limits. If the delivered energy would be in comfortable limitsfor such oversensitive individuals, treatment therapy would beinefficient. Therefore, the analgesic effect of electrostimulation maybe desirable. Another beneficial effect is that if patient feels pain,the patient usually increases muscle tone in this area. Long lastingmuscle contraction may cause pain in the muscle part for several daysand/or damage of muscle fibers. Long lasting muscle contraction istherefore not only uncomfortable but it also may affect the blood andlymph circulation. Whereas the treatment may be improved by sufficientfluid circulation during and/or after the treatment.

Pain is a multi-factor phenomenon and there are several mechanismsthrough which the analgesic effect of electrotherapy is achieved.

It is possible to distinguish several pain management approaches. One ofthem is called gate-control theory based on a premise that the pain istransmitted through a “gate” in substantia gelatinosa in spinal dorsalhorn. Stimulation of large-diameter fibers Aβactivates inhibitory spinalinterneurons which prevent the passage of information by activated thinAδ and C nerve fibres to the brain. If signal from activated Aδ and Cnerve fibers is not inhibited such signal results in pain in the brain.Another pain theory is pattern theory premises that the pain excitementis transmitted from the peripheral receptor to the CNS in a patterncoded energy and the pain is interpreted by decoding the energy in CNS.

The last pain management theory is called release of endogenous opioidsbased on the effect of endorphins, enkephalins and dynorphins. Thesecretion of these three endogenous opioids may be caused of nerve fiberstimulation by low repetition rate in range 5 Hz to 20 Hz or by highrepetition rate in range 110 Hz to 150 Hz time-varying magnetic and/orelectric field or by the low repetition rate envelope.

Pain is usually simply defined as an unpleasant sense and emotionalexperience, connected with actual or potential damage of the tissue. Weusually distinguish between acute and chronic pain. Acute pain isshort-lasting (maximum several days or weeks). It is caused bymechanical damage of the tissue or by a disease, comes immediately afterthe painful stimulus and subsides after its ending. The intensity ofacute pain depends on the intensity of stimulation. On the other hand,chronic pain is long-lasting (more than 3 months) or recurrent. Itsintensity does not depend on the intensity of stimulation; emotionsparticularly play a leading role.

Effects of electrotherapy it is important to understand especially themodulating factors influencing the perception and transfer of thepainful stimulus. An analgesic effect may occur by stimulation of typeAβ nerve fibres by frequency 50-150 Hz and/or type C-thin fibers byfrequency 2-8 Hz.

For most of analgesic effect it is possible to choose several types ofcurrents e.g. diadynamic current, currents changing in long lastingperiod, bipolar amplitude modulated medium frequency currents, TENSand/or, other of interferential currents (in range of 0.1-1 kHz).Frequencies of the currents are described above.

A myorelaxation effect may be achieved. Myorelaxation effect causes atleast partially decrease the muscle fiber tone. Myorelaxative effect maybe beneficial for improving homogeneity of delivered RF therapy and/orfaster regeneration of the soft tissue and/or more comfortable therapyalso. Long lasting permanent muscle contraction may slower body fluidcirculation e.g. lymph and blood circulation, that has crucial therapyeffect. Long lasting muscle contraction is also very exhausting. Forbetter results the therapy should be comfortable because thepsychological state of the patient influences human metabolism.

In order to provide myorelaxation, the amplitude modulated mediumfrequency currents with frequency of the pulse envelope in a range of5-300 Hz or 10-200 Hz or 10-150 Hz may be used. It is also possible touse TENS and/or other.

Muscle fibers stimulation may be achieved, increasing muscle tone,muscle strengthening, restoration of feeling the muscle, relaxation ofthe musculature and/or stretching musculature.

Muscle fiber stimulation by electrotherapy may be important duringand/or as a part of treatment provided RF therapy. Muscle stimulationincreases blood flow and lymph circulation. It may improve removing oftreated cells and/or prevent of hot spots creation. Moreover internalmassage stimulation of adjoining tissues improves homogeneity of tissueand dispersing of the delivered energy. Another beneficial effect is forexample during fat removing with the RF therapy. RF therapy may changestructure of the fat tissue. The muscle fiber stimulation may provideinternal massage, which may be for obese patient more effective thanclassical massage.

Muscle stimulation may be provided by e.g. intermittent direct currents,alternating currents (medium-frequency and TENS currents), faradiccurrent as a method for multiple stimulation and/or others. Frequency ofthe currents and/or its envelope is typically in the range from 0.1 Hzto 200 Hz in preferred embodiment or from 0.1 Hz to 150 Hz in morepreferred embodiment or from 0.1 to 140 Hz in the most preferred.

Muscle stimulation may be at least partial muscle contraction, e.g.:gluteus maximus, gluteus medius, gluteus minimus, sartorius muscle,rectus femoris muscle, vastus lateralis muscle, vastus intermediusmuscle, vastus medialis muscle, biceps femoris muscle, semitendinosusmuscle and semimembranosus muscle, pectineus muscle, external obturatormuscle, gracilis muscle, adductor longus muscle, adductor brevis muscleand adductor magnus muscle, tensor fasciae latae muscle, latissimusdorsi muscle, abdominal internal oblique muscle, abdominal externaloblique muscle, transverse abdominal muscle, pyramidalis muscle, bicepsbrachii muscle, brachialis muscle, coracobrachialis muscle, tricepsbrachii muscle, pectoralis muscle, spinal muscles, thoracic muscles.Muscles in pelvic and/or adjacent to pelvic floor may also bestimulated, helping to resolve problems with incontinence, improve sexlife and/or restore relaxed muscles after birth.

A trophic effect may be achieved. A trophic effect created byelectrotherapy may have beneficial influence on homogeneity, energydissipation, creating of hot spots and/or other. Trophic effect mayeliminate the risk of hyperthermia injury and/or panniculitis, which arepossible to occur during RF treatments. It is also believed that atrophic effect also improves the cell metabolism (e.g. fat cell) thatmay have with delivered RF therapy synergic effect and better resultnamely for treating of fat tissue, removing of the cellulite.

Since the mechanism of hyperemia in various types of therapies isdifferent, it is necessary to take these mechanisms into account to beable to select a suitable therapy. Generally, galvanization can berecommended. Other recommended frequency may be especially longitudinal(capillary hyperemia, vessel eutonization), low-frequency currents ofthe frequency 30-60 Hz or 10-100 Hz. The trophic effect may be partlycaused by bringing energy into the organism and energy is used by cells(or other structures) for their activity. The trophic hyperemic effectis also usually connected with the analgesic effect.

An anti-edematous effect may be achieved. Anti-edematous effect may bepractically connected with hyperemia, vessel eutonisation and highercapillary permeability. Therefore the therapies referred to as trophicare also anti-edematous. This could be beneficial for stimulation oflymph and blood circulation and removing of treated cells during, beforeand/or after treatment therapy include RF therapy (e.g. fat removing).

Described frequencies are just examples of the most frequently usedfrequencies in some embodiments. Described ranges of frequencies are notlimited. The individual embodiments may be applied to the tissuesimultaneously, successively and/or in overlay.

The electrostimulation may be provided in a combined manner wherevarious treatments with various effects may be achieved. As anillustrative example, the electromagnetic stimulation may be dosed intrains where the first train of stimulation may achieve different effectthan second or other successive train of stimulation. Therefore, thetreatment may provide muscle fibers stimulation followed by relaxation,during continual or pulsed radiofrequency thermal heating.

Absolute value of voltage between the electrotherapy electrodes operatedin bipolar, unipolar mode (electric current flow between more than twoelectrodes) and/or provided to at least one electrotherapy electrode maybe in range between 0.8 V and 10 kV; or in range between 1 V and 1 kV;or in range between 1 V and 300 V or in range between 1 V and 100 V.

Current density of electrotherapy for non-galvanic current may be inrange between 0.1 mA·cm⁻² and 30 mA·cm⁻², or in range between 0.1mA·cm⁻² and 10 mA·cm⁻², or in range between 0.1 mA·cm⁻² and 4 mA·cm⁻²,or in range between 0.1 mA·cm⁻² and 2 mA·cm⁻²; for galvanic current maybe preferably in range between 0.05 mA·cm⁻² and 3 mA·cm⁻², or in rangebetween 0.1 mA·cm⁻² and 1 mA·cm⁻², or in range between 0.01 mA·cm⁻² and0.5 mA·cm⁻².

Electrostimulation may be provided by monopolar or bipolar mode.

During bipolar electrotherapy mode two or more electrodes may be used.If polarity of at least one electrode has a non-zero value in a group ofthe electrodes during bipolar mode, the group of the electrodes has toinclude at least one electrode with opposite polarity value. Absolutevalues of both electrode polarities may or may not be equal. In bipolarelectrostimulation mode stimulating signal passes through the softtissue between electrodes with opposite polarities.

Distance between two electrodes operating in bipolar mode may be inrange between 0.1 cm and 40 cm or in range between 1 cm and 30 cm, or inrange between 1 cm and 20 cm.

During monopolar electrotherapy mode stimulating signal may be inducedby excitement of action potential by changing polarity of one electrodethat change polarization in the nerve fiber and/or neuromuscular plague.

During electrotherapy may be combined bipolar and monopolarelectrotherapy mode or may be used just one of them.

A handheld applicator may include one or more electrodes providingelectrotherapy. Providing effective electrotherapy e.g. musclestimulation and/or analgesic with movable one or more electrodes duringthe treatment may be complicated. In order to provide effectiveanalgesic and/or muscle stimulation treatment after placing applicator'shead into contact with the patient's body, applicator may create one ormore electric testing pulses provided to the patient's soft tissue.

Testing pulses may have increasing repetition rate, increasing intensityor may be predefined according other criteria in the treatment protocol.Testing pulses may be monitored. Feedback information from testingpulses, measurable values on the electrodes or soft tissue under orbetween the electrodes e.g. changed impedance of at least part of thesoft tissue or changed potential in the soft tissue, may be evaluatedand optimal treatment parameters in order to cause physiological effectby electrotherapy (e.g. creating nerve action potential excitation andmuscle contraction) may be sets up and electrotherapy may starts.

Testing pulses may be one or more pulses. Testing pulses for actualapplicator and/or electrode(s) position may last between severalpicoseconds to several seconds. Testing pulses may be applied every timeapplicator change location on the patient's body, target area or softtissue parameters changed more than is sets up in the treatmentprotocol. Testing pulses may be also applied with defined time delaywhich is defined in the treatment protocol.

Testing pulses may be used to automatically choose an area on thepatient's body where electrotherapy may be provided and/or may be usedfor setting optimal parameters for chosen type of applied electrotherapy(e.g. intensity, repetition rate, type of pulse sequence, shape ofprovided pulses and/or other parameters).

An optimal area on the patient body for electrotherapy may be saved intothe device memory and testing pulses may not be provided every time whentreated area is the same.

Recognition of the same treated area on the patient's body may recognizeby tracing applicator moves and/or by other mechanism.

At least one electrode for electrotherapy may be included in thehandheld applicator and at least other one electrode for electrotherapymay be located attached to the patient's body. Electrostimulationaccording such device embodiment may be based on moving with theapplicator according treatment pattern across the patient surface.

Treatment patterns may be based on circular moves, curvilinear movesand/or linear moves creating treatment pattern.

All electrodes providing electrotherapy may be located outside of thehandheld applicator in contact with the patient's body. Such electrodemay communicate with the applicator and may adjust electrotherapyaccording to moving with the applicator.

Electrodes providing electrotherapy may be connect to the rest of thedevice by wire and/or may have its own power supply 101 (e.g. at leastone batteries) and also may communicate with the device (control unit102) wirelessly.

A wireless electrode may include its own power supply (e.g. battery) andmay include hardware and/or software equipment in order to be able tocommunicate with control unit 102 of the device, other electrode(s) andbe able to provide treatment. Wireless electrode may be attached topatient's body and provide any type of treatment therapy (e.g. RFtherapy and/or electrotherapy) without wire connection with the rest ofthe device.

Communication, attaching applicator(s) to patient's body, providedtreatment patterns and/or other features may be used as described inU.S. Provisional Application No. 62/375,796 incorporated herein byreference.

Placing the stationary electrodes providing electrotherapy may be basedon operator experience, by observing physiological effect (e.g. musclecontraction) and/or may be based on impedance changes and/or specificelectric potential changes as was described above.

In FIG. 1 is captured one exemplary schematic diagram of a proposedsystem. The system may comprise power supply 101, control unit 102, userinterference 103, one or more sensors 105 and applicator 104 providingRF therapy and/or electrotherapy.

Electrodes that may provide RF therapy and also electrotherapy may beswitching between these two types of therapies during one treatmentsession. If the treatment protocol defines switching between RF therapyand any electrotherapy on one electrode at least once during 20 secondprovided RF therapy last at least 40%, or 50%, or 70% or 90% of timewhen the electrode provides any kind of therapy.

Power supply 101 may be managed by control unit 102. Regulation ofdelivered energy may be controlled by control unit 102. The control unit102 may also evaluate feedback information from one or more sensors 105,and/or treatment parameters from user interface 103. Control unit 102may contain one or more cooperating units. Control and cooperation unitsare elements of the device that has influence on treatment parameters ofthe therapy(e.g. therapy time, amount of delivered energy, burst timing,frequency of provided energy, intensity of energy, controlling switchingon/off different group of electrode/s, shape of the pulses and others).

The user interface may allow the operator to change and/or set up thetreatment parameters. Treatment parameters may be set up in the range ofsafe thresholds (e.g. individually for each therapy). Thresholdtreatment parameters may be operatively changed depending on therapyand/or detected parameters from the feedback sensors. Safe dosage of thedelivered energy and/or dependence of each parameter may be pre-set.Course of treatment may be provided by computer and/or operator.Treatment may be guided manually, automatically and/orsemi-automatically where some of the treatment parameters were set upmanually. A computer may change inappropriately set up parameters and/oralert the operator.

If treatment parameters are evaluated as safe, therapy may start. It maybe possible to adjust parameters of the therapy or add therapy typese.g. galvanic current, pulse direct current and alternating current.Treatment may be time limited and stopped by if values of one or moredetected parameters reached their limits e.g. time, time andtemperature. Safe thresholds may be dependent on treated body part ortarget area. The constitution of the treated soft tissue is important.This may be classified by e.g. ultrasound, from the information ofbackscattered radiofrequency wave.

Treatment therapy may be guided with partially or fully predeterminedtreatment protocol or without predetermined protocol where the operatormay adjust some or all parameters of the treatment. The system mayprovide information to the control unit about electrode(s) connected andready to participate in the treatment.

Treatment may be guided automatically without need of an operator.Treatment is guided according a defined treatment protocol. During suchtreatment feedback information from one or more sensors may be evaluatedin control unit 102 and according feedback information treatmentparameters may be regulated in order to provide safe treatment.

The device may have one or more sensors 105 providing feedbackinformation in order to improve efficiency of the treatment andminimized health risk. Based on feedback treatment information therapyparameters could be manually or automatically or semi-automaticallyoptimized or therapy could be interrupted (as was mentioned above). Thedevice may contain different types of sensors 105 for monitoring deviceparameters and/or monitoring of body biological, physical, chemicaland/or other parameters (e.g. a reactive sensor; an electrochemicalsensor; a biosensor; a biochemical sensor; a temperature sensor; sensorfor measuring distance of applicator from the patient surface, from somearea of the patient soft tissue and/or from other applicator; a sorptionsensor; a pH sensor; a voltage sensor; a detector of moving velocity,gyroscope detecting moves and/or change of position; photo sensor;sensor measuring viscosity; a camera; a sensor measuring fluorescence ofthe patient surface; a sound detector; a current sensor; sensor formeasuring of specific heat capacity of human/animal tissue; sensor formeasuring impedance; permittivity; conductivity; susceptibility, valueof electric field, magnetic field and/or any suitable sensor or sensorsmeasuring biological parameters and/or combination thereof e.g.: sensorfor measuring dermal tensile forces; sensor for measuring the activityof the muscle; a muscle contraction forces; skin elasticity). The devicemay also include at least one contact sensor for monitoring ofapplicator and/or electrode or more electrodes contact with bodysurface.

Each sensor 105 may provide feedback information to control energydelivery and/or other treatment parameters to improve efficiency of atreatment and/or minimized health risk and/or discomfort during thetreatment. The treatment therapy parameters may be manually orautomatically or semi-automatically optimized based on feedbackinformation. If the treatment parameters are evaluated as not-safe, thetreatment maybe stopped or the values treatment parameters may bechanged.

Treatment therapy may be guided with partially or fully predeterminedtreatment protocol or without predetermined treatment protocol. Resultof this is that the treatment may be carried automatically (allowingtreatment without operator), semi- automatically and/or by operator.Operator may set up and/or adjust any parameter of treatment therapybefore and/or during the treatment.

The applicator may contain a suction unit to create negative pressureand may be attached to patient's body. The applicator may containplug-in connector for connecting one or more electrodes.

At least one spacing object may be provided between the applicator andpatient's skin surface. A spacing object is shown in FIG. 3 . Spacingobject 1 may improve transfer of electromagnetic field into the softtissue. This could be provided by the spacing object itself and/orfiller inside of the spacing object and/or thanks to design of theobject. Various materials having suitable dielectric constant, densityand/or other parameters may be used in order to prevent backscatteringof the electromagnetic wave and improve transfer of electromagnetic waveto the soft tissue and improve effectiveness of the treatment.Backscattering may occur at the interface of the materials withdifferent physical parameters, analogous to optical phenomenon at theinterface of different refractive indexes.

Inner space of the spacing object 1 may be separated or partly separatedinto one or more chambers 4 a-4 d by walls 5 a-5 c. Each chamber mayinclude one or more cells which may be provide optimal ducting for theflowing substance and/or which may strengthen the walls of chamber inorder to preserve the shape of the chamber and object. Each part of thespacing object inner space may have different filler and thereforefunction. Filling of the inner space of the spacing object 1 may be doneduring the manufacturing process. According to another embodiment theinner space may be filled and/or circulated during the therapy throughone or more inlet/outlet valves 6 a-6 d. Changing and/or removing of theinner substance of the object may be provided through the inlet/outletvalve 6 a-6 d also.

The spacing object 1 and/or filler inside may have advantageousdielectric constants (permittivity, permeability, conductivity) and/orother parameters and constants (thermal conductivity, specific heatcapacity . . . etc.). and may be used as focusing element, absorbingelement, polarizing element, dispersing element, transmitting element,massaging element, reflecting element of backscattered waves, fortransfer electromagnetic wave, cooler, heater and/or creator of thermalgradient in the soft tissue of the patient

Filler of the spacing object may be gaseous, liquid and/or from solidmaterial. Spacing object may be composed of any kind of ceramics,plastic material, rubber, textile material, metal, polymeric materialsand/or other material that improve any therapy parameter/s. In someembodiment may be important to choose material and/or construction ofthe object to provide stable form and/or shape of the spacing object.Spacing object may be flexible and/or rigid and may imitate curves ofthe body contour.

Filler of the spacing object may provide polarization and/or reflectionand/or may focus delivered electromagnetic energy and/or may be used asa filter of electromagnetic wave and/or may adjust orientation of thewave vector of the electromagnetic wave as was mentioned below.Polarization of the electromagnetic wave has different impact ondifferent molecules and environments, so polarization may influenceabsorption, dispersion, penetration, targeting and/or reflection ofelectromagnetic wave. Polarization of the electromagnetic wave may becreated by anisotropic arrangement of dielectric films (e.g. bypoly(vinyl alcohol) doped by iodine or other substances based ondichroic polarizers principle) and/or by principle of the phaseretardation plate and/or by material and/or geometry of the antenna.Some polarization and reflection element may have crucial influence toprevent creating hot spots due to changing of the orientation of thewave vector end selective modification of the component of theelectromagnetic wave.

Treatment by electromagnetic field and spacing object enabling changingof temperature and/or other parameters (permittivity, permeability,conductivity and/or their parameters) and/or its one or more componentmay create temperature gradients across the soft tissue of the patient.This is important because tissue dielectric parameters (e.g. impedance,conductivity and/or other related dielectric parameters) change withdifferent temperature and frequency of applied electromagnetic waves.Targeting of thermal gradient by applied electromagnetic field andcontinuous but more preferably sequential heating and/or cooling of thepatient surface by the spacing object may improve the effect of thetreatment and minimize health risk.

Spacing object 1 may prevent harmful influence of edge effects inconnection with delivering energy by electrodes. Preventing the edgeeffect is achieved via dispersion of the electromagnetic energy, coolingand/or changing orientation of the Poyting's vector of theelectromagnetic field in the object. Object 1 may also cause the higherhomogeneity of the electromagnetic field.

Cooling or heating of tissue may be provided by a spacing object filledwith a suitable substance (mostly liquid or gaseous substance e.g.water, water doped NaCl, ethanol, air, N2, CO2, air and others). Theparameters of the substance such as temperature, viscosity, flow etc.may be monitored by one or more sensors (e.g. temperature and/orviscosity sensors and/or sensor measure inducted currents or chemicalchanges of the substance). Monitored parameters may provide feedbackinformation to control unit for regulate flow of the substance throughthe spacing object. Object 1 may be extended by complementary connectionof other one or more chambers. Extension of spacing object may sharefiller or may have different function e.g. protection of different areafrom overheating, over-radiation and/or other influences, differentcooling program, modulation of the delivered energy to the patient(polarizing, filtering etc.) and/or other functions (focusing etc.).

Thermal gradients are represented in FIG. 2 . In some embodiment it ispossible to create a thermal gradient by heating and/or cooling surfaceof the patient skin with highest or lowest temperature on the skinsurface FIG. 2 a) and/or it is possible to create temperature gradientwith highest or lowest temperature beneath the surface of the softtissue FIG. 2 b). The effect described at FIG. 2 b) may be provided bysequential heating/cooling of the patient surface and/or by focusing ofdelivered electromagnetic and/or thermal energy.

In one method, the patient's surface (epidermis) temperature may bemaintained in a range between 20° C. to 44° C., or in range between 30°C. to 44° C., or in range between 30° C. to 40° C. Such treatment methodmay maintain lower temperature of the patient's epidermis than istemperature in the treated patient's adipose tissue.

The increase of the temperature in the dermal and the sub dermal tissuesalso affects the triple-helix structure of collagen fibers contained insuch tissues. This may result in remodeling and rejuvenation ofcollagen, increase of skin density and dermal thickening

Spacing 1 located between the patient's soft tissue surface and thetreatment energy source may have specific properties and influenceparameters of treatment energy as described in U.S. ProvisionalApplication No. 62/331,072, incorporated herein by reference.

In one aspect the device is designed as a belt that may be modularlymodified by adding and/or removing one or more part of the device (e.g.:applicators, treatment units and/or others) before and/or during thetreatment. The belt is designed to fit to any type and size of treatedpatient body area. In one preferred embodiment the belt is in touch withpatient's body surface matches the curvature of patient's body. Size ofthe belt may be variable by stretching and/or by plugging and/orremoving of one or more parts of the belt.

In another embodiment the belt may be considered as a block of at leasttwo treatment applicators attached in optimal working distance to thepatient's body. Optimal working distance may be any distance from theskin of the patient or in direct contact with the skin of the patient.Applicators may have various sizes and shapes.

One or more treatment applicators may communicate with each other and/orwith one or more control units via cables, wireless and/or viaconnection through the belt. Transfer of the information through thecable may be based on conductive mechanism and/or via mechanism used inan optical fibers and/or as a wave guide provide transfer of differenttypes of the energy (e.g.: sonic, electric, electro-magnetic, pressureby liquid or gas substances and/or other). The communication may provideinformation about locations and/or type of the applicator/applicators,treatment protocol, treatment parameters and other information. In someembodiments it is possible to provide treatment between multipleapplicators, (e.g.: multiple monopolar, unipolar and/or multipolarapparatus) or focusing of some energy sources (e.g.: RF, ultrasound,light), that may improve some treatment (e.g.: removing of fattytissue).

Large scale modularity by changing hardware and/or treatment pattern byplacing of at least one applicator and/or other parts of the device,(e.g.: adding, removing, reorganization and/or changing of spacingbetween of at least one applicator and/or other part of the device)before and/or during the treatment allows actualization of the deviceand prevents obsolescence of the device. The belt may or may not containsupporting matrix. The belt may be flexible, whole or partly elastic andmay be adapted to patient surface of arbitrary size and shape. Thischaracteristic helps to provide optimal energy transfer from anapplicator to the patient soft tissue. Improved contact with the patientskin or surface may decrease or prevent an edge effect, backscatteringof delivered energy and/or provides better conditions for collectingfeedback information. Supporting matrix may also be connected to upperside of the applicator, keep one or more applicators in touch with thepatient surface, and not be in touch with the patient.

A treatment pattern creates pattern by switching between applicatorsand/or treatment elements providing one or more types of the therapyacross the patient surface. A treatment pattern may include differenttypes of switching sequences, and also include at least one of: aspecific treatment therapy is applied; a selection of applicators and/ortreatment elements applying specific treatments; timing of the appliedtherapy; the distance between at least two applicators; duration of thetreatment therapy applied; body location where the treatment therapyapplied; cycle of applying one or more specific treatment therapies.

A treatment pattern may provide information about applying one or moretypes of the treatment therapies and their manner (e.g.: simultaneous,sequential and/or applying of one or more treatment therapies with someoverlay). A treatment pattern may simulate moving of the one or moreapplicators guided by an operator by switching between applicatorsand/or treatment elements of one or more applicators and/or one or moretreatment therapies. Simulated moves may be circular, zig-zag, spiral,other geometrical pattern, scanning and/or other pattern that may becreated by moving the applicator guided by operator. A treatment patternmay also be used for scanning of the patient soft tissue.

A hardware pattern is a composition of the device and placement of theparts of the device. A hardware pattern also includes placement of theapplicators which is in some embodiments not limited (e.g.: in thesupporting matrix, on the patient surface etc.), placement of thetreatment unit, and/or other devices adjacent/at working distance to thesoft tissue (which includes direct, indirect or no contact).

The belt may be a block of more than one applicator with and/or withoutsupporting matrix and/or with or without spacing object. Location ofindividual applicators (optionally including different types ofapplicators) creates a hardware pattern. A computer and/or operator maychoose several treatment therapies and procedures that can worksimultaneously, with some overlay and/or sequentially during thetreatment time and/or adjust one or more parameters of the procedurebefore and/or during the treatment.

According another embodiment applicator may also create treatmentpattern by switching on/off of some treatment elements included in theapplicator. In FIG. 6 element number 62 is the applicator's activesurface with multiple treatment elements 63. Applicator may containdifferent shapes of the treatment elements and number of the treatmentelements in one applicator is not limited. Spacing between treatmentelements may be different across the applicator's active surface.Treatment elements may also be movable during the treatment and/orspacing between treatment elements may also be variable during the timeof the treatment. Switching on/off of some treatment elements during thetime may be defined by protocol of the treatment procedure and maycreate multiple different types of the treatment pattern that may changeduring one treatment procedure. All of the treatment elements in oneapplicator may provide one therapy or in some other embodiment of theapplicator, treatment elements of one applicator may provide differenttypes of the therapies. Treatment pattern created by one applicator mayalso be created by moving of one or more treatment elements included inthe applicator.

In another embodiment parts of the device may be attached to patientbody and/or to other parts of the device by a sticky layer betweencontact surfaces and/or by high adhesive layer applied on one or morecontacts surfaces. Contact between parts of the device and/or betweenone or more parts of the device and patient surface may be provided bygravitational force, by high roughness of the contact surfaces, byelectric forces, by magnetic forces, by rails, by elastic, partiallyelastic and/or non-elastic stripes, by Lace, by Velcro, zipper, bytacks, by creating lower air pressure between contact surfaces bysuction mechanism, by interaction between polar and/or non-polar groupof the contact surface, by fastening mechanism described below and/or byother physical, chemical, mechanical interaction between parts of thedevice and/or between patient surface. Some parts of the device may alsobe connected to each other by individual elements of a scaffold.

The belt may include supporting matrix that can hold one or moreapplicators and/or its treatment elements in touch with patient's bodysurface and/or it may also hold one or more applicators at an optimalworking distance from the patient surface. The patient surface istypically the skin of the patient. However, the patient body surface mayalternatively be some spacing object e.g.: clothing worn over the skin,a sheet, pad or other thin (0.1-2 mm) covering over the skin, and/or athicker spacing object.

Spacing object may be located between any parts of the device and/orbetween patient and some parts of the device. Because of mechanical,structural, physical and/or chemical properties of this spacing object,spacing object may provide and/or improve attachment of any parts of thedevice and/or some parts of the device and patient body surfacetogether.

The belt may encircle the patient's torso and/or limb, and optionallyincluding a fastening mechanism that may have various embodiments andmay help to fixe applicator(s) to supporting matrix.

The supporting matrix may include fastening mechanism for attachingapplicators to supporting matrix, for attaching some parts of thesupporting matrix together, for attaching supporting matrix to spacingobject and/or to patient's body and/or for attaching other parts of thedevice together. Fastening mechanism may also provide attaching one ormore applicators to spacing object and/or to patient's body. Fasteningmechanism may be e.g.: snap, clamp, some rails, adhesive polymer,pre-prepared holes, Velcro, zipper and/or other implemented fasteningmechanisms and/or snap mechanisms) and/or may be provided byelectromagnetic field, by magnetic field, by pressure lower thanatmospheric pressure, by adhesive material, by interaction of chemicalbounding interaction (interaction between polar and nonpolar groups)and/or others methods similar to method described above and/or othermechanisms.

The supporting matrix may contain fastening mechanism which may bepermanent or removable from the supporting matrix. Position of thefastening mechanism may be variable and/or fixed before, during and/orafter treatment. Fastening mechanisms may have various spacing betweeneach other, different shapes, sizes and/or mechanism, how to be attachedsome of the applicators and/or how to be attached to supporting matrixand/or how to provide other types of the connection described above(based on physical, chemical and/or mechanical interaction). Fasteningmechanism may be attached to supporting matrix and/or to arbitrary otherpart of the device at arbitrary location by similar manner as it isdescribed above - attachment of the applicator to patient's body and/orto spacing object. Fastening mechanism may be also attached tosupporting matrix and/or other parts of the device by mechanicalconnection.

One applicator may be attached across multiple fastening mechanisms(e.g.: applicators provide mechanical massage with movable and/or staticelement, RF therapy and/or other applicators provided different and/ormultiple types of the therapies). It is not necessary that supportingmatrix encircling whole patient torso and/or limb etc. In someembodiments applicators may be attached to both sides of the supportingmatrix.

The belt may comprise applicators applied on the patient surface and/ora thin and/or a thicker spacing object and fixed by textile, polymericand/or other strips. The strips may be at least partially elastic. Theapplicator(s) may be attached at the right working distance by one ormore stripes located in front and/or back side of the applicator.Suitable elastic materials are elastomers or also elastic fabrics. Theelastic belt material also adapts to respiratory movements and/or othermovement of the patient.

The applicators may have different sizes and shapes, to improvetreatment results and/or flexibility of the belt. Each applicator may befixed to supporting matrix at arbitrary position e.g.: by inserting anapplicator into the pocket in the support matrix, by Velcro and looptape, by one or more magnets, by tacks or fasteners, fastening strapsand/or by other fastening mechanism 51 as may be seen in FIG. 5 and/orby other manner described above.

The supporting matrix may be attached to the patient by different waydescribed above and/or by encircling patient body and connect some partsof supporting matrix to each other and/or by external positive pressureacting on supporting matrix in direction to the patient surface.Supporting matrix may be designed as one or combination of more pieceswhere at least one piece has elastic properties. Supporting matrix maybe designed as elastic clothes (e.g. elastic trousers, sleeves, shirtetc.) to fix one or more applicators at optimal location on the patientbody and/or at optimal working distance with the patient body at theright position. Supporting matrix may be fixed at specific body locationof the patient body and/or may be movable along the patient body.

Some parts of the supporting matrix may be created of flexible, elasticand/or rigid materials e.g.: polymeric materials, ceramics, textilematerials, conductive parts and/or other materials. The supportingmatrix may be at least partially flexible and/or elastic to provideimproved contact with the patient body and/or set appropriate workingdistance for one or more applicators.

The support matrix may also contain apertures of different sizes andshapes. The support matrix may contain cooling/heating elements, massageelements that may move across the belt area and/or one or more sensors.In some embodiment mechanism for moving with attached applicators and/orother part of the belt may be provided according defined pattern. Atrack or path for the applicator may be created by rails (e.g.:applicator may be moved along them by mechanical forces based onpressure and/or tensile forces) and/or by a path created from conductiveelements and applicators may be moved along them by electric, magneticand/or electromagnetic forces.

Moving of one or more applicators and/or other parts of the belt acrossthe patient body may also be provided by moving of the supportingmatrix. Move of the supporting matrix may be provided by expansionand/or shrinking of some parts of the supporting matrix and/or by movingwith the supporting matrix along the spacing object (e.g. by mechanic,electric, magnetic and/or combination of these forces) and/or byattaching supporting matrix to an another movable parts of the device(e.g.: mechanical arm, construction on rails).

The supporting matrix may have several embodiments. One of suchembodiment is depicted in FIG. 5 where the support matrix consists ofguiding scaffold 52, with the one or more applicators 53 attachable tothe scaffold 52 by fastening mechanism 51. The supporting matrix mayinclude conductive parts that may provide communication betweenapplicators, communication between applicators and central control unitand/or communication between at least one applicator and treatment unit.Conductive parts in the supporting matrix may also provide power supplyto the applicator(s). Applicator may also include one or morerechargeable batteries as a source of energy. These batteries may berecharged through the supporting matrix and/or through the spacingobject.

In another embodiment belt may be a flexible textile and/or polymericsheet. This sheet may contain conductive elements that may providecommunication, power supply, determine of one or more applicatorslocation and type, contact with the supporting matrix and/or patientsurface, provide information about treatment protocol as was mentionedabove and/or other features. In some embodiments supporting matrix mayalso include cooling and/or heating components. This embodiment of thebelt may also include spacing object.

As a result, so-called plug and play methods may be used to modifyhardware pattern of the applicators attached to patient and/or tosupporting matrix (sorting and/or choosing of the applicators). Thisplug and play method provides a large scale of modularity. Thesupporting matrix also may recognize which applicator is positioned orfixed in which slot in the supporting matrix and the control unit mayassign and/or accept predefined treatment protocols. Recognition of theapplicator may also be provided by one or more central control unitsand/or by any other one or more control units. Localization of theapplicator may be provided by some specific sensors described below.

Several applicators may cooperate with each other. FIG. 4 describescooperation of multiple applicators 41 a, 41 b, 41 c that may providesome treatment therapy (e.g. multipolar RF therapy symbolized by fieldlines 42 and/or others) to the patient 43. Cooperation of multiple unitsmay be used for different therapies (e.g.: RF, ultrasound, light,massage, cooling/heating, electrotherapy, magneto-therapy and/or othertherapies) in order to provide bipolar and/or multipolar treatmentacross large patient area, better targeting of delivered therapy, betterfocusing of delivered signal, creating of some gradient in the softtissue (e.g. thermal gradient, etc.), better homogeneity of providedtherapy across large patient area and/or volume of the soft tissue.

Cooperation of multiple applicators and/or treatment elements mayenlarge treatment variability (e.g. treatment depth, focusing), sincethe electrode of each applicator and/or treatment element may representsone pole of multipolar treatment.

RF energy and electrostimulation may help with drug delivery through theskin of the patient. The present system and method may also involve anapplication of the substance and/or mixture of substances causing aphysiological change in the body of the patient. In addition, themixture (e.g. green tea extract) may include not yet characterizedsubstances. Application of the substance and/or mixture of thesubstances may provide patient with a more comfort and/or improve theperformance of the system.

In one embodiment, the substance may modulate normal metabolism and/orbasal metabolism rate of the patient's body. It may provide accelerationto the metabolism related to the apoptotic cells. Such substances mayinclude alkaloids (e.g. xanthines), antithyroid agents, metformin,octreotide and a like.

Substances may modulate efferocytosis, which is the process by whichdying cells are removed by phagocytic cells. This may provideacceleration and improvement in the dead cells removal. Such substancemay include prostaglandins and their analogues, modified lipids (e.g.lysophosphatidylserine, lipoxins, resolvins, protectins and/ormaresins), lipoprotein lipase inhibitors, nitric oxide secretionstimulators, alkaloids (e.g. xanthines), aspirin, antioxidants (e.g.ascorbic acid), derivatives of carbohydrates and a like.

Delivered substances may modulate lipolysis rate. In case of applicationof electromagnetic energy to the adipocytes it may provide another wayof removal of the adipose cells, which may be independent from thetreatment method. Such substances may include terpens (e.g. forskolin),catecholamins, hormons (e.g. leptin, growth hormone and/ortestosterone), alkaloids (e.g. synephrin), phosphodiesterase inhibitors(e.g. xanthins), polyphenols, peptides (e.g. natriuretic peptides),amino acids and a like.

Delivered substances may modulate hydration of the patient. Suchsubstances and/or mixtures may include xanthines, lactated Ringer'ssolution, physiological saline solution and a like.

Delivered substances may modulate circulatory system of the patient.This may provide the higher rate of blood circulation, which may resultin faster cooling rate of the skin. Such substances may includecatecholamines, alkaloids (e.g. xanthins), flavanols and a like.

Delivered substances may induce the reversible decrease or absence ofsensation in the specific part of the patient's body. This may provide acertain level of comfort to heat-sensitive patient. Such substances mayinclude lidocaine, benzocaine, menthol and a like.

Delivered substances may shield the electromagnetic radiation from thepatient's body. This effect may be used for protection of sensitiveparts of the human body. Such substances may include mixture containingmetal nanoparticles, mixture containing polymer particles and a like.

Delivered substances may modulate the effect the electromagneticradiation applied on the patient's body. This may accelerate removal ofthe desired tissue, for example by heating of the tissue and/orincreasing the effect of the applied radiations. Such substances mayinclude carotens, chlorophylls, flavanols and a like.

Delivered substances may be used singularly or in various combinationswith at least one suitable substance, which may be not listed as anexample. For example, lidocain providing a local anesthesia may becombined with prilocaine to provide improved effect. The substanceand/or mixture of the substances may be administered in different timerelated to the tissue treatment. It may be administered before thetreatment, during the treatment and after the treatment.

Delivered substances may be administered in order of seconds, hours oreven days to accumulate in the desired tissue. The subsequentapplication of the electromagnetic radiation may modulate the action ofthe accumulated substance and/or be modulated by the action of thesubstance. According the example of this embodiment, the chromophore maybe accumulated in the treated tissue, such as adipocytes, before thetreatment. Chromophore may then absorb electromagnetic radiation andheat the tissue nearby. Presented active agents or in this text calledsubstances may have significant influence to treatment therapy as isdescribed in U.S. Provisional Application No. 62/331,060 incorporatedherein by reference.

Delivered substances may be applied to the particular part of thetissue, which is not a target of the therapy. It may change the bloodperfusion, conductivity, hydration and other characteristics of thenon-targeted tissue. In another embodiment, the targeted tissue may beadipose tissue and the non-targeted tissue may be any other soft tissue.

Substances mentioned above may by delivered to patient's body before,during and/or after treatment session.

The present methods and devices provide for improving skin viability,skin and body rejuvenation, skin tightening, scar removing, spider veinsremoving, restoring and restructuring collagen in the soft tissue bodyshaping (e.g. butt lifting, breast lifting etc.), body contouring,circumferential reduction, cellulite removing, adipose tissue reduction,adipose tissue removing, muscle relaxation, relaxation of muscle tone,muscle building, muscle strengthening, treating and stimulating pelvicfloor tissue and adjacent muscles, remodeling of outer part of genitalstreat sexual dysfunctions, treat or reduce incontinence problems,accelerate neocolagenesis, improving blood flow, lymph flow, stimulationof lymph nodes, movement of the vessels, bruising removing, reduceswelling, enhancing vitamin D metabolism, restoring nerve signaltransfer, accelerate body metabolism, accelerate cell metabolism,pigmentation disorders, tattoos removal, stress relive, micro-dermalabrasion, hair removal, shortening of recovery time after injury and/orother skin and body affliction using application of RF energy andelectrical stimulation to the soft tissue.

Special treatment may be targeted to areas near human genitals (e.g.:improve pigment homogeneity, downsizing of pubic lips and/or othertarget area) and/or treatment may be targeted inside of the humancavities as anus or vagina in order to treat pelvic floor and/or otherareas inside the patient's body.

During treatment of human cavities at least part of the applicatorand/or treatment energy source may be inserted inside of human cavityand may be there placed stationary or may be moved with circular and/orlinear moves according any Cartesian coordinate.

According other embodiments an applicator is used for treating of humancavities and it may also be designed to treat outer side of genitalssimultaneously with treating inside area of human cavity.

Part of an applicator for human cavity treatment may have a changeablevolume. Such part may be inflated, deflated and/or stretch in order toprovide optimal contact with soft tissue in the human cavity and soprovide optimal energy transfer from at least one treatment energysource to the patient's soft tissue. Changing volume of at least part ofthe applicator may be by inflating/deflating such part with air orliquid and/or such volume changing applicator's part may change itsvolume and/or shape by properties of the material based on humidity ortemperature changes and/or by changing geometry inside of the applicatorcaused by electromotor.

Treatment energy source providing electrotherapy in human cavity may belocated on or near the applicator's surface and treatment energy sourceproviding RF therapy may be located inside and or on the surface of theapplicator.

An applicator and treatment effects, treated tissues and/or otherfeatures are described in U.S. patent application Ser. No. 15/478,943,incorporated herein by reference.

One treatment session may last between 1 minute to 120 minutes, orbetween 5 minutes to 40 minutes, or between 10 minutes to 30 minutes orbetween 10 to 20 minutes

Recommended delay between two treatment sessions may be influence byprovided intensities of delivered energy to the patient's body, providedtherapies and/or provided active substances. Recommended delay betweentwo treatment sessions may be in range 1 hour to 20 days, or in range 8hours to 14 days, or in range 24 hours to 7 days.

The device and method may be used for treating patients for patientswith BMI in range between 18 to 40 and/or with subcutaneous adiposetissue layer thickness in range between 1 mm to 15 cm, or between 3 mmto 7 cm, or between 3 mm to 3 cm.

Thus, novel methods and devices have been shown and described. Variouschanges and substitutions may of course be made without departing fromthe spirit and scope of the invention. The invention, therefore, shouldnot be limited, except by the following claims, and their equivalents.

1-30. (canceled)
 31. A device for providing treatment by radiofrequencyfield and electric current to a patient, the device comprising: a firstapplicator configured to be in a stationary position during treatmentand to be attached to a body part of the patient, the first applicatorcomprising: a radiofrequency electrode configured to provide aradiofrequency field to heat tissue within the body part of the patient;a second applicator, comprising: an electrotherapy electrode configuredto provide electric current to stimulate a muscle of the body part ofthe patient; and a control unit configured to: control theradiofrequency field; and control the electric current.
 32. The deviceof claim 31, further comprising a substance configured to be applied onthe body part under the first applicator or the second applicator and tocause a physiological change in the body part of the patient during thetreatment.
 33. The device of claim 32, wherein the substance isconfigured to provide hydration of the body part.
 34. The device ofclaim 31, wherein the second applicator is configured to be attached tothe body part of the patient, and wherein the electrotherapy electrodeis configured to be in contact with the body part, when the secondapplicator is attached to the body part.
 35. The device of claim 34,wherein the first applicator and the second applicator are configured tobe attached to the body part of the patient by a flexible belt or by anadhesive material.
 36. The device of claim 34, wherein the electriccurrent is provided within a series of envelopes, and wherein theenvelopes repeat with a frequency in a range of 0.1 Hz to 140 Hz. 37.The device of claim 34, wherein the radiofrequency electrode is one ofone or more bipolar radiofrequency electrodes, and wherein theradiofrequency field has a frequency in a range of 0.1 MHz to 25 GHz.38. The device of claim 34, wherein the electric current has a currentdensity in a range of 0.1 mA/cm² to 30 mA/cm², wherein the stimulationof the muscle causes a contraction of the muscle, and wherein theradiofrequency field has an energy flux density on a surface of theradiofrequency electrode in a range of 0.5 mW/mm² to 1 W/mm².
 39. Adevice for providing treatment by radiofrequency field and electriccurrent to a patient, the device comprising: a first applicatorconfigured to provide a radiofrequency field, the first applicatorcomprising: a radiofrequency electrode configured to provide theradiofrequency field having a frequency in a range of 0.1 MHz to 25 GHzto the body part to heat a body part of the patient; a second applicatorconfigured to provide electric current, the second applicatorcomprising: an electrotherapy electrode located on an outer side of thesecond applicator and configured to be placed in contact with the bodypart of the patient, wherein the electrotherapy electrode is configuredto provide the electric current having a frequency in a range of 0 Hz to12 kHz to the body part to stimulate a muscle of the body part of thepatient; a control unit configured to control the radiofrequency fieldand the electric current based on one or more treatment protocols; and auser interface configured to allow an operator of the device to selectthe one or more treatment protocols.
 40. The device of claim 39, whereinthe electric current is pulsed electric current having a frequency ofpulses in a range of 0.1 Hz to 200 Hz and a current density in a rangeof 0.1 mA/cm² to 30 mA/cm².
 41. The device of claim 39, wherein thecontrol unit is configured to recognize the first applicator coupled tothe control unit, wherein the control unit is configured to recognizethe second applicator coupled to the control unit, and wherein thecontrol unit is configured to provide information about the coupling ofthe first applicator or the second applicator with the control unit tothe user interface and to provide the one or more treatment protocols tobe selected by the operator based on this information.
 42. The device ofclaim 39, wherein the first applicator and the second applicator areconfigured to be attached to the body part of the patient by an adhesivematerial.
 43. The device of claim 39, wherein the first applicator andthe second applicator are configured to be attached to the body part ofthe patient by a flexible belt, and wherein the body part comprises anabdomen, a buttock, saddlebags, or an arm.
 44. The device of claim 39,further comprising a sensor configured to provide feedback informationindicating an impedance of the body part.
 45. The device of claim 43,wherein the control unit is configured to provide the radiofrequencyfield by the first applicator before or after providing the electriccurrent by the second applicator.
 46. A device for providing treatmentby radiofrequency field and electric current to a patient, the devicecomprising: an applicator configured to be attached to a body part ofthe patient, comprising: a first electrode located on an outer side ofthe applicator and configured to: be placed in contact with the bodypart of the patient during the treatment; provide a radiofrequency fieldhaving a frequency in a range of 0.1 MHz to 25 GHz to heat the body partof the patient; and provide electric current to stimulate a muscle ofthe body part of the patient; and a control unit configured to controlthe radiofrequency field and the electric current.
 47. The device ofclaim 46, wherein the control unit is configured to control theradiofrequency field to heat the body part to a temperature in a rangeof 30° C. to 50° C.
 48. The device of claim 46, further comprising asubstance configured to be applied on the body part under the applicatorand to provide hydration of the body part.
 49. The device of claim 46,wherein the applicator is configured to be attached to the body part ofthe patient by an adhesive material.
 50. The device of claim 46, furthercomprising a flexible belt, wherein the applicator is configured to bein a stationary position during treatment and to be attached to the bodypart of the patient by the flexible belt.
 51. The device of claim 46,wherein the first electrode is configured to change between providingthe radiofrequency field and the electric current during the sametreatment, wherein the electric current is pulsed electric currenthaving a current density in a range of 0.1 mA/cm² to 30 mA/cm² and apulse shape of rectangular, triangular, or exponential, and wherein avoltage provided to the first electrode when providing the electriccurrent is in a range of 1 V to 100 V.
 52. The device of claim 46,wherein the applicator further comprises: a second electrode configuredto provide the electric current to the body part of the patient andconfigured to have opposite polarity than the first electrode whenproviding the electric current.
 53. The device of claim 52, wherein adistance between the first electrode and the second electrode is in arange of 0.1 cm to 40 cm.
 54. A device for providing treatment byradiofrequency field and electric current to a patient, the devicecomprising: an applicator, comprising: a radiofrequency electrodeconfigured to provide a radiofrequency field having a frequency in arange of 0.1 MHz to 25 GHz to heat a body part of the patient; and anelectrotherapy electrode located on an outer side of the applicator andconfigured to: be placed in contact with the body part of the patient;and provide electric current to stimulate a muscle of the body part ofthe patient, wherein a distance between the radiofrequency electrode andthe electrotherapy electrode is in a range of 0.1 cm to 40 cm; and acontrol unit configured to control the radiofrequency field and theelectric current.
 55. The device of claim 54, wherein the control unitis configured to provide a series of pulses of the electric current, andwherein the series of pulses repeat with a frequency in a range of 0.1Hz to 140 Hz.
 56. The device of claim 54, wherein the radiofrequencyfield is configured to heat the body part to a temperature in a range of30° C. to 50° C.
 57. The device of claim 54, further comprising asubstance configured to be applied on the body part of the patient underthe applicator, wherein the substance causes a physiological change inthe body part during the treatment.
 58. The device of claim 56, whereinthe substance is configured to provide hydration of the body part. 59.The device of claim 54, wherein the electric current has a currentdensity in a range of range of 0.1 mA/cm² and 30 mA/cm², wherein avoltage provided to the electrotherapy electrode when providing theelectric current is in a range of 1 V to 300 V, wherein the stimulationof the muscle causes a contraction of the muscle, and wherein theradiofrequency field has an energy flux density on a surface of theelectrode in a range of 0.01 mW/mm2 to 10 W/mm2.
 60. The device of claim59, wherein the muscle comprises at least one of gluteus maximus,gluteus medius, gluteus minimus, sartorius muscle, rectus femorismuscle, vastus lateralis muscle, vastus intermedius muscle, vastusmedialis muscle, biceps femoris muscle, semitendinosus muscle andsemimembranosus muscle, pectineus muscle, external obturator muscle,gracilis muscle, adductor longus muscle, adductor brevis muscle andadductor magnus muscle, tensor fasciae latae muscle, latissimus dorsimuscle, abdominal internal oblique muscle, abdominal external obliquemuscle, transverse abdominal muscle, pyramidalis muscle, biceps brachiimuscle, brachialis muscle, coracobrachialis muscle, triceps brachiimuscle, pectoralis muscle, spinal muscles, or thoracic muscles.